Drug product
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
D-0489-2026
Product summary
- Firm
- Harrow Eye LLC
- Event
- Event 98766
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 50,900 units
- Official record key
drug-enforcement:D-0489-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 1X68, 1X69, Exp. Date 05/31/2027.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility